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Drager Isolette® 8000 Infant Incubator - HSA Registration DE0007664

Access comprehensive regulatory information for Drager Isolette® 8000 Infant Incubator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007664 and owned by Draeger Medical Systems, Inc.. The device was registered on September 23, 2011.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0007664
Drager Isolette® 8000 Infant Incubator
HSA Registration Number: DE0007664
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Product Description

Intended to provide a controlled environment for both premature and full-term babies. It can be used in any department of the hospital that provides neonatal and infant care, including all levels of the Neonatal Intensive Care Unit (NICU), Special Baby Care Unit, Step Down Nursery, Newborn Nursery and Pediatrics.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0007664
Registration Date
September 23, 2011
Retention Due Date
September 22, 2025
Product Owner
Short Name
Draeger Medical
Address
3135 Quarry Road, Telford, PA 18969, UNITED STATES
Registrant
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Importer
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Model Information
Model Name(s)
Tray 3020 SoftBed mattress Scale weight, 5kg Iris Port sleeve, disposable, 100 Suction bottle, disposable, box of 20, 800 cc Air filter, replacement, 4 Adapter Cable, skin probe Probe 4, skin temperature, disposable, box of 10, CE Probe 5, skin temperature, reusable Probe 5, large skin temperature, box of 10, YSI Grommet Oxygen tank bracket assembly, Isolette I.V. pole assembly Scale Assembly, Isolette non-OIML Scale Assembly, OIML, Isolette for OIML Cell, oxygen I.V. resuscitator bag holder assembly Chart holder assembly Hinged Mayo tray, Cable organization assembly Standard cam adapter Cam adapter, threaded, assembly Utility hook assembly Oxygen assembly, DISS fitting, male Oxygen assembly, DISS fitting, female Oxygen assembly, NIST fitting, male Ventilator tubing support kit Kit, HFV access door with grommets Evaporator assembly, C2P, 230V Isolette 8000 Infant Incubator Humidity system option, C2P, 230V Humidy reservoir assembly, C2P Hose/plug assembly, condenstiaon management, 20 Drain plug with O-ring
Model Identifier(s)
M24678 MP01401 MU01732 MU03876 MU10918 MU12504 MU12520 MU12525 MU12533 MU12551 MU12609 MU12952 MU12955 MU13060 MU13089 MU13223 MU14802 MU14812 MU14814 MU14818 MU14822 MU14828 MU14833 MU16945 MU16946 MU16947 MU18660 MU18986 MU19894 MU20600 MU21082 MU21093 MU21120 MU21156